Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Skin Neoplasms

Distribution of the sun protection educational workbook

Distribution of general skin care information

Subjects will read a workbook about sun protection

Workbook

June K. Robinson, M.D.

This study is being done to evaluate the effectiveness of a Sun Protection Strategies workbook for kidney transplant recipients. Since the medication taken to preserve the kidney transplant puts kidney transplant recipients at an increased risk of developing skin cancer. The program will help people learn about how to practice effective sun protection after the transplant.

Cognitive interview about the Sun Protection Strategies workbook will be performed with up to 25 kidney transplant recipients (KTR) who have participated in past surveys. A second phase of the study involves 156 KTRs that will be asked to take part in a randomized controlled trial evaluating the fully developed sun protective strategies workbook.

Kidney transplant recipients (KTRs) are at risk to develop skin cancer. Adequate sun protection after transplantation can reduce the risk of developing skin cancer. In 2006, the National Kidney Foundation (NKF) found that sun protection education delivery and content varied among transplantation centers. Clinicians rarely knew when to initiate education about skin cancer risks and prevention including timing and scope, and rarely demonstrated understanding of the importance of reminders for and repeated education of patients (National Kidney Foundation 2006).

Aims:

1. To explore culturally sensitive use of terms describing ethnic cultural perceptions of sun burning, pigment darkening after sun exposure and description of skin color by the amount of photo-protective pigment in the skin.
2. To pilot test the sun protection workbook with English speaking KTRs representing the 3 ethnic groups: White, Black and Hispanic.
3. To assess the effectiveness of an education intervention encouraging the use of sun protection strategies.
4. To explore understanding of the importance of sun protection and the KTRs confidence in their being able to practice sun protection.

Evaluation of Sun Protection Education for Kidney Transplant Recipients

Subjects will complete self-report surveys of behavior prior to educational intervention and 6- 8 weeks after the educational intervention

Northwestern University

Principal Investigator

Blood and Lymph Conditions

Immune System Diseases

Infections

Symptoms and General Pathology

Rare Diseases

Lymphoma

Epstein-Barr Virus Infections

Lymphoproliferative Disorders

Virus Diseases

Communicable Diseases

Lymphatic Diseases

Immunoproliferative Disorders

Herpesviridae Infections

DNA Virus Infections

Tumor Virus Infections

Lymphosarcoma

Post-transplant Lymphoproliferative Disease

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Hematinics

Gastrointestinal Agents

Rituximab

Immunomodulating Agents

Liver Extracts

Pancrelipase

Pancreatin

Participants who have failed rituximab will receive IV tabelecleucel.

Participants who have failed both rituximab and chemotherapy will receive IV tabelecleucel.

Tabelecleucel is being investigated as an off-the-shelf, allogeneic T-cell immunotherapy for the treatment of EBV+ malignancies and diseases.

tabelecleucel

Aditi Mehta, DO

Amandeep Salhotra, MD

Huynh Cao, MD

Neena Kapoor, MD

Herbert Eradat, MD

William Asch, MD

Udeme Ekong, MD

Amer Beitinjaneh, MD, MPH, MSc

Suhag Parikh, MD

Jean Koff, MD

Sonali Chaudhury, MD

Satayaijt Kosuri, MD

Patrick Hagen, MD

Jean Yared, MD

Sarah Nikiforow, MD

Armin Ghobadi, MD

Koen Van Besien, MD

Ran Reshef, MD

Kevin Curran, MD

Michael Kent, MD

Matthew McKinney, MD

Hanna Rabi, MD

Robert Baiocchi, MD, PhD

Nemecek Eneida, MD

Nancy Bunin, MD

Michelle Hudspeth, MD

Bhagirathbhai Dholaria, MD

Luis Pineiro, MD

Tamra Slone, MD

Kris Michael Mahadeo, MD

James Butterworth, MD

Shyam Panicker, MD, MBBS, MRCP, FRACP, FRCPA

Daniel Chambers, MBBS, MRCP, FRACP, MD

Devendra Hiwase, MD

Rachel Conyers, MD, MBBS, FRACP

Duncan Purtill, MD, MBBS, FRACP, FRCPA

Nina Worel, MD

Willems Evelyne, MD

Daan Dierickx, MD

Victor Lewis, MD

Joerg Krueger, MD

Arjun Law, MD

Edouard Forcade, MD

Eolia Brissot, MD

Franck Morschhauser, MD

Benedicte Neven, MD

Sylvain Choquet, MD

Roberto Cairoli, MD

Patrizia Comoli, MD

Simona Sica, MD

Franco Locatelli, MD

Giaccone Luisa, MD

Eva González-Barca, MD

Lucrecia Yanez, MD

Pere Barba, MD

Gillen Oarbeascoa, MD

Jose Perez-Simon, MD

Juan Montoro, MD

Sridhar Chaganti, MD

Daniele Avenoso, MD

Eduardo Olavarria, MD

The purpose of this study is to determine the clinical benefit and characterize the safety profile of tabelecleucel for the treatment of Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) in the setting of (1) solid organ transplant (SOT) after failure of rituximab and rituximab plus chemotherapy or (2) allogeneic hematopoietic cell transplant (HCT) after failure of rituximab.

This is a multicenter, open-label, phase 3 study to assess the efficacy and safety of tabelecleucel for the treatment of EBV+ PTLD in the setting of SOT after failure of rituximab and rituximab plus chemotherapy (SOT cohort) or HCT after failure of rituximab (HCT cohort).

Enrollment will be preceded by confirmation of availability of partially human leukocyte antigen (HLA) matched and restricted tabelecleucel for the participant.

Study procedures and product administration will be the same for each cohort. Tabelecleucel will be administered in cycles lasting 5 weeks (35 days). During each cycle, participants will receive intravenous tabelecleucel at a dose of 2×10\^6 cells/kg on Days 1, 8, and 15, followed by observation through Day 35. Treatment will continue until maximal response, unacceptable toxicity, initiation of non protocol therapy, or failure of tabelecleucel with up to 2 different HLA restrictions (SOT cohort) or up to 4 different HLA restrictions (HCT cohort). The study includes a total of 5 years of follow-up for disease and survival status.

This protocol has been amended to include the HCT cohort from clinical study ATA129-EBV-301 (NCT03392142).

NOTE, 29 April 2020: Enrollment is temporarily paused at study site/locations with status "active, not recruiting" due to COVID-19 restrictions.

Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease (EBV+ PTLD) After Failure of Rituximab or Rituximab and Chemotherapy

Multicenter, Open-Label, Phase 3 Study of Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Subjects With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure of Rituximab or Rituximab and Chemotherapy

Atara Biotherapeutics

Distribution of the internet-based sun protection educational program.

Distribution of general skin care information.

Prior to summer, KTRs who agree to participate will receive a text message with their access code to the Internet intervention to access from their homes on a personal device. After online completion of baseline assessments, participants will be randomized to receive the intervention or general skin care information (control). Following the initial use, the participants may revisit the Internet intervention on a personal device or at the doctor's office on a tablet PC. Over the next 6 weeks, sun protection text reminders will be sent to intervention KTRs' cell phones and they will respond that they read the message. Control participants will receive text messages about general skin care.

Internet-based sun protection education

This study is being done to evaluate the effectiveness of a Sun Protection Strategies internet-based program for kidney transplant recipients. Since the medication taken to preserve the kidney transplant puts kidney transplant recipients at increased risk of developing a sunburn as well a skin cancer, the program will help people learn how to practice effective sun protection for their condition.

Cognitive interviews about an internet-based sun protection strategies program will be performed with up to 45 kidney transplant recipients (KTRs) who have participated in past surveys. A second group of 150 KTRs will be asked to evaluate the internet-based module for the effectiveness of information. A third group of 12 KTRs will be asked to evaluate the internet-based module for usability. A fourth group of 160 KTRs will be asked to take part in a randomized controlled trial evaluating the fully developed internet-based sun protection strategies program.

Kidney transplant recipients (KTRs) are at risk to develop skin cancer. Adequate sun protection after transplantation can reduce the risk of developing skin cancer. In 2006, the National Kidney Foundation (NKF) found that sun protection education delivery and content varied among transplantation centers. Clinicians rarely knew when to initiate education about skin cancer risks and prevention including timing and scope, and rarely demonstrated understanding of the importance of reminders for and repeated education of patients. (National Kidney Foundation 2006) The NKF supported standard, formal, well timed skin cancer prevention information and sending reminders to KTRs at the beginning of summer.

Aims:

1. To explore culturally sensitive use of terms describing ethnic cultural perceptions of sun burning, pigment darkening after sun exposure and description of skin color by the amount of photoprotective pigment in the skin.
2. To pilot test the internet-based sun protection brochure with English speaking KTRs representing 3 ethnic groups: White, Black and Hispanic.
3. To explore understanding of the importance of sun protection and the KTRs' confidence in their being able to practice sun protection.

Sun Protection of Kidney Transplant Recipients

Internet-Based Sun Protection Program for Kidney Transplantation Recipients

Use of sun protection will be measured using 10 questions about what a person regularly does in summer during a warm sunny day and during a cloudy day regarding: 1) use of sunscreen; 2) wearing hat; 3) shirt with sleeves; 4) sunglasses; and 5) staying in the shade. The scores for these questions will be summed to derive a dichotomous measure of sun protection use (1= use of sun protection often or always; 0 otherwise).

Three telephone interviews will be done on Mondays after at least 2 holiday weekends in which the weather is reported as sunny or partly sunny by the national weather service (Memorial Day, 4th of July and Labor Day) as well as one sunny non-holiday weekend. The KTR will be asked if they experienced a sunburn or skin irritation. The response will be dichotomous (yes/no).

Skin pigment as measured by reflectance spectrophotometry, ranging from limited \[225 area-under-the-curve (AUIC)\] to dense (75 AUIC).

Research Professor of Dermatology

Gland and Hormone Related Diseases

Neoplasm Metastasis

Hyperparathyroidism

Hyperparathyroidism, Secondary

Neoplastic Processes

Parathyroid Diseases

Endocrine System Diseases

Oculocerebral Syndrome With Hypopigmentation

Hormones

Parathyroid Hormone

Paricalcitol capsules 1- 2 mcg/day/pts for 26 weeks

Paricalcitol

Standard therapy for hyperparathyroidism for 26 weeks

Standard therapy

The risk of fracture for kidney transplant recipients is 4 times higher that of the general population. The hyperparathyroidism plays a key role in the maintenance or development of post-transplant alterations of bone remodelling.

Renal transplant patients are at high risk of hyperparathyroidism, largely because of long-lasting renal insufficiency before transplant, and of progressive deterioration of kidney function because of chronic allograft nephropathy (a disease of proteinuria and progressive decline of the glomerular filtration rate).In hemodialysis patients, intravenous paricalcitol (19-nor-1,25-dihydroxyvitamin D2), a new vitamin D analogue, achieves a faster and more effective normalization of parathyroid hormone (PTH) levels than calcitriol (1,25-dihydroxyvitamin D3), an effect that is associated with smaller changes in serum calcium and phosphorus levels.

Whether oral paricalcitol may help achieving a prompt reduction in serum PTH levels and, secondarily, in urinary protein excretion in renal transplant recipients with secondary hyperparathyroidism is worth investigating.

BACKGROUND The risk of fracture for kidney transplant recipients is 4 times higher that of the general population. The pathogenesis of post-transplant bone disease is multifactorial, but hyperparathyroidism plays a key role in the maintenance or development of post-transplant alterations of bone remodelling. Vitamin D and its analogues are key components of treatment aimed to prevent or ameliorate secondary hyperparathyroidism in patients with chronic kidney disease (CKD). In hemodialysis patients, intravenous paricalcitol (19-nor-1,25-dihydroxyvitamin D2), a new vitamin D analogue, achieves a faster and more effective normalization of parathyroid hormone (PTH) levels than calcitriol (1,25-dihydroxyvitamin D3), an effect that is associated with smaller changes in serum calcium and phosphorus levels. Preliminary evidence is also available that in pre-dialysis patients with CKD and secondary hyperparathyroidism, treatment with oral paricalcitol may also reduce urinary protein excretion, an effect that is independent of concomitant treatment with agents that block the renin-angiotensin system and that in the long-term might translate into slower progression to end stage kidney disease and need for renal replacement therapy.

Renal transplant patients are at high risk of hyperparathyroidism, largely because of long-lasting renal insufficiency before transplant, and of progressive deterioration of kidney function because of chronic allograft nephropathy (a disease of proteinuria and progressive decline of the glomerular filtration rate). Whether oral paricalcitol may help achieving a prompt reduction in serum PTH levels and, secondarily, in urinary protein excretion in renal transplant recipients with secondary hyperparathyroidism is worth investigating.

AIMS Primary To evaluate whether 6-months treatment with paricalcitol may achieve a prompt and effective reduction in PTH serum levels in stable renal transplant patients with secondary hyperparathyroidism.

DESIGN This will be a Prospective, Randomized, Open label, Cross-over study of 6-months with Paricalcitol or standard treatment for hyperparathyroidism.

After one month wash-out from any form of Vitamin D therapy, patients satisfying the inclusion/exclusion criteria will be randomized to two treatment arms:

1. Paricalcitol capsules 1- 2 mcg/day/pts for 26 weeks
2. Standard therapy for hyperparathyroidism for 26 weeks At the end of the first treatment period with Paricalcitol or Standard therapy each patient will cross-over to the other treatment.

After baseline evaluation eligible patients will enter a 6 months treatment period whit oral paricalcitol (1-2 mcg/day), or standard treatment for hyperparathyroidism, added-on background therapy whit calcium and phosphate supplementation as deemed clinically appropriate.

Paricalcitol in Reducing Parathyroid Hormone Levels and Ameliorating Markers of Bone Remodelling in Renal Transplant Recipients With Secondary Hyperparathyroidism

A PROSPECTIVE, PILOT, CROSS-OVER STUDY TO ASSESS THE EFFICACY OF PARICALCITOL IN REDUCING PARATHYROID HORMONE LEVELS AND AMELIORATING MARKERS OF BONE REMODELLING IN RENAL TRANSPLANT RECIPIENTS WITH SECONDARY HYPERPARATHYROIDISM

Mario Negri Institute for Pharmacological Research

Heart and Blood Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Multiple Myeloma

Neoplasms, Plasma Cell

Kidney Diseases

Kidney Failure, Chronic

Renal Insufficiency

Graft vs Host Disease

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Renal Insufficiency, Chronic

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Homologous Wasting Disease

Combined bone marrow and kidney transplant

Thomas Spitzer, MD

A. Benedict Cosimi, MD

The purpose of this study is to determine whether a combined bone marrow and kidney transplant will be effective in treating stage II or greater multiple myeloma and associated kidney failure. This study will determine whether transplant rejection and the need for immunosuppressive drugs are decreased with this combined transplant approach.

In very limited human testing, a combined kidney and bone marrow transplant appears to be safe and effective in treating multiple myeloma and associated kidney failure. This study will evaluate this approach in 10 patients with kidney failure due to or in association with stage II or greater multiple myeloma. Treatment prior to transplant will include cyclophosphamide, ATGAM (a lymphocyte-specific immunosuppressant), local radiation to the thymus, and cyclosporine (an immunosuppressive drug).

An infusion of donor bone marrow and a kidney graft from a closely matched, related donor will be transplanted simultaneously. An additional infusion of donor white blood cells may be administered between day 45 and 74 after transplant in an effort to eliminate any remaining cancer cells. Patients will remain on cyclosporine for a defined period of time. The cyclosporine doses will be slowly decreased and stopped if graft rejection and graft-versus-host disease do not occur.

Each participant will be involved in the study for 3 years; this includes the intervention phase (time from initial screening at approximately 7 days before transplant through 100 days after the transplant) and continued follow-up visits for at least 2 years following the transplant.

Combined Bone Marrow and Kidney Transplant for Multiple Myeloma With Kidney Failure

Combined HLA-matched Bone Marrow and Kidney Transplantation for Multiple Myeloma With Renal Failure

Immune Tolerance Network (ITN)

National Institute of Allergy and Infectious Diseases (NIAID)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Sun Protection Education for Kidney Transplant Recipients	NCT01844713	Unspecified Com... Disorder Relate...	Workbook	18 Years - 85 Years	Northwestern University
Evaluation of Sun Protection Education for Kidney Transplant Recipients	NCT01844713	Unspecified Com... Disorder Relate...	Workbook	18 Years - 85 Years	Northwestern University
Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease (EBV+ PTLD) After Failure of Rituximab or Rituximab and Chemotherapy	NCT03394365	Epstein-Barr Vi... Solid Organ Tra... Lymphoprolifera... Allogeneic Hema... Stem Cell Trans...	tabelecleucel	-	Atara Biotherapeutics
Sun Protection of Kidney Transplant Recipients	NCT01646099	Unspecified Com... Disorder Relate...	Internet-based ...	18 Years - 85 Years	Northwestern University
Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease (EBV+ PTLD) After Failure of Rituximab or Rituximab and Chemotherapy	NCT03394365	Epstein-Barr Vi... Solid Organ Tra... Lymphoprolifera... Allogeneic Hema... Stem Cell Trans...	tabelecleucel	-	Atara Biotherapeutics
Paricalcitol in Reducing Parathyroid Hormone Levels and Ameliorating Markers of Bone Remodelling in Renal Transplant Recipients With Secondary Hyperparathyroidism	NCT01220050	Renal Transplan... Secondary Hyper...	Paricalcitol Standard therap...	18 Years - 80 Years	Mario Negri Institute for Pharmacological Research
Paricalcitol in Reducing Parathyroid Hormone Levels and Ameliorating Markers of Bone Remodelling in Renal Transplant Recipients With Secondary Hyperparathyroidism	NCT01220050	Renal Transplan... Secondary Hyper...	Paricalcitol Standard therap...	18 Years - 80 Years	Mario Negri Institute for Pharmacological Research
Combined Bone Marrow and Kidney Transplant for Multiple Myeloma With Kidney Failure	NCT00062621	Kidney Failure,... Multiple Myelom...	Combined bone m...	18 Years - 65 Years	National Institute of Allergy and Infectious Diseases (NIAID)

Spots Global Cancer Trial Database for renal transplant